Ram M. Email & Phone Number

United States

-Led R&D and manufacturing/quality teams supporting pharmaceutical and biotech clients, overseeing complex research initiatives and ensuring on-time delivery of key milestones.-Managed cross-functional teams, aligning scientific research, marketing, and product development teams to ensure seamless execution of projects.-Provided scientific leadership & technical expertise, ensuring compliance with FDA and ISO guidelines.

-Managed quality assurance systems for FDA-regulated manufacturing, ensuring compliance with SQF, USDA, and FDA standards.-Developed and implemented SOPs for new testing equipment and methodologies, including HPLC, to support the robust quality of manufactured products.-Spearheaded efforts to automate laboratory systems, improving efficiency and product quality.-Collaborated with cross-functional teams, including R&D and marketing, to ensure product development aligned with regulatory standards and consumer needs.-Led non-conformance investigations and CAPA implementation, ensuring corrective actions were taken to address product issues.

-Led initiatives to achieve regulatory certifications, including SQF, USDA Organic, and WSDA, ensuring operational compliance.-Acted as an internal auditor and liaison with external auditors, ensuring adherence to quality systems and regulatory requirements.-Worked closely with R&D teams to support product development and shelf-life studies, ensuring scientific rigor in product testing and data analysis.-Developed and maintained quality KPIs, improving product quality and efficiency.

-Scaled up two microbiology laboratories serving food processing plants, achieving ISO 17025 accreditation for both facilities.-Implemented quality management systems and ensured adherence to GMP/GLP guidelines.-Led data analysis and root cause analysis initiatives to improve laboratory efficiency and product safety.-Designed and validated microbiological and chemical testing methodologies to ensure regulatory compliance and scientific accuracy.

-Conducted innovative research on drug efficacy for osteoarthritis and developed biocompatible materials for heart tissue engineering.-Developed a lab-on-chip micropillar device for leukemia detection, improving cancer diagnosis accuracy in developing regions.-Applied data analysis techniques (LabVIEW, Matlab, GraphPad Prism, JMP) to enhance the performance and efficacy of biomedical devices and research outcomes.